0 Valutazioni
ID

44648

Descrizione

ODM derived from http://clinicaltrials.gov/show/NCT01146444

collegamento

http://clinicaltrials.gov/show/NCT01146444

Keywords

versioni (3)
  1. 06/12/13 06/12/13 - Martin Dugas
  2. 17/04/14 17/04/14 - Julian Varghese
  3. 27/09/21 27/09/21 -
Caricato su

27 settembre 2021

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

  • i più nuovi
  • i più vecchi
  • Popolare
  • i più nuovi
    • i più nuovi
    • i più vecchi
    • Popolare

    Non ci sono commenti

    Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

    Eligibility NCT01146444 Cutaneous Lupus Erythematosus

    Tedesco Inglese

    Eligibility

    1 moduli  
    1. StudyEvent: Eligibility
      1. Eligibility
    Einschlusskriterien
    Descrizione

    Einschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425202
    Alter 18 bis 85 Jahre
    Descrizione

    age 18 Years to 85 Years

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Patients with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE), or lupus erythematosus tumidus (LET) according to the Düsseldorf Classification 2004 (Kuhn and Ruzicka 2004) confirmed by histological analysis.
    Descrizione

    Patients with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE), or lupus erythematosus tumidus (LET) according to the Düsseldorf Classification 2004 (Kuhn and Ruzicka 2004) confirmed by histological analysis.

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0024140
    SNOMED CT 2011_0131
    239891002
    MedDRA 14.1
    10057903
    ICD-10-CM Version 2010
    L93.1
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C0024138
    SNOMED CT 2011_0131
    200938002
    MedDRA 14.1
    10013072
    ICD-10-CM Version 2010
    L93.0
    UMLS CUI 2011AA
    C0406636
    SNOMED CT 2011_0131
    200941006
    UMLS CUI 2011AA
    C0205462
    SNOMED CT 2011_0131
    67151002
    UMLS CUI 2011AA
    C0750484
    Women of childbearing potential with a negative pregnancy test at screening (urine test) and using a medically accepted contraceptive regimen (intra-uterine device, partner's vasectomy, >3 months previous hormonal contraception (oestrogen plus gestagen pill, depot injections, or subcutaneous depot) combined with a barrier method (preservative, vaginal diaphragm, cervical cap, spermicide) during the study and for 8 weeks after the last UV exposure.
    Descrizione

    Women of childbearing potential with a negative pregnancy test at screening (urine test) and using a medically accepted contraceptive regimen (intra-uterine device, partner's vasectomy, >3 months previous hormonal contraception (oestrogen plus gestagen pill, depot injections, or subcutaneous depot) combined with a barrier method (preservative, vaginal diaphragm, cervical cap, spermicide) during the study and for 8 weeks after the last UV exposure.

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0043210
    SNOMED CT 2011_0131
    224526002
    UMLS CUI 2011AA
    C1148523
    UMLS CUI 2011AA
    C0237399
    UMLS CUI 2011AA
    C0430057
    SNOMED CT 2011_0131
    167254001
    MedDRA 14.1
    10036577
    UMLS CUI 2011AA
    C0700589
    SNOMED CT 2011_0131
    146680009
    MedDRA 14.1
    10010808
    UMLS CUI 2011AA
    C0021900
    SNOMED CT 2011_0131
    268460000
    MedDRA 14.1
    10022745
    UMLS CUI 2011AA
    C0420842
    SNOMED CT 2011_0131
    268457007
    UMLS CUI 2011AA
    CL424941
    UMLS CUI 2011AA
    C0014939
    SNOMED CT 2011_0131
    41598000, 61946003
    LOINC Version 232
    MTHU003480
    UMLS CUI 2011AA
    C0033306
    SNOMED CT 2011_0131
    116614001, 20249007
    UMLS CUI 2011AA
    C0419530
    SNOMED CT 2011_0131
    268464009
    UMLS CUI 2011AA
    C0205195
    SNOMED CT 2011_0131
    89780004
    UMLS CUI 2011AA
    C0004764
    SNOMED CT 2011_0131
    225370004
    UMLS CUI 2011AA
    C0677582
    UMLS CUI 2011AA
    C0042241
    SNOMED CT 2011_0131
    20359006
    UMLS CUI 2011AA
    C0493327
    SNOMED CT 2011_0131
    368441006
    MedDRA 14.1
    10007183
    UMLS CUI 2011AA
    C0037862
    SNOMED CT 2011_0131
    425484006
    Women clinically sterile (post-menopausal, undergone hysterectomy or tubal ligation).
    Descrizione

    Women clinically sterile (post-menopausal, undergone hysterectomy or tubal ligation).

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0043210
    SNOMED CT 2011_0131
    224526002
    UMLS CUI 2011AA
    C0205210
    SNOMED CT 2011_0131
    58147004
    UMLS CUI 2011AA
    C0021359
    SNOMED CT 2011_0131
    8619003
    MedDRA 14.1
    10021926
    UMLS CUI 2011AA
    C0232970
    SNOMED CT 2011_0131
    76498008
    UMLS CUI 2011AA
    C0020699
    SNOMED CT 2011_0131
    236886002
    MedDRA 14.1
    10021151
    UMLS CUI 2011AA
    C0520483
    SNOMED CT 2011_0131
    77543007
    MedDRA 14.1
    10044722
    Actively cooperating to participate in the study, to follow the instructions of the investigator and to attend the centre at the agreed times.
    Descrizione

    Actively cooperating to participate in the study, to follow the instructions of the investigator and to attend the centre at the agreed times.

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0392337
    UMLS CUI 2011AA
    C0679823
    HL7 V3 2006_05
    PART
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C0525058
    Development of skin lesions any time under current systemic treatment if patient is receiving systemic medication for the treatment of CLE.
    Descrizione

    Development of skin lesions any time under current systemic treatment if patient is receiving systemic medication for the treatment of CLE.

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C1511795
    UMLS CUI 2011AA
    C0037284
    SNOMED CT 2011_0131
    95324001
    MedDRA 14.1
    10040882
    UMLS CUI 2011AA
    C0521116
    SNOMED CT 2011_0131
    15240007
    UMLS CUI 2011AA
    C1515119
    UMLS CUI 2011AA
    C0024137
    SNOMED CT 2011_0131
    7119001
    MedDRA 14.1
    10056509
    Signed informed consent form after the nature of the study has been fully explained.
    Descrizione

    Signed informed consent form after the nature of the study has been fully explained.

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0021430
    Ausschlusskriterien
    Descrizione

    Ausschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425201
    Pregnancy or lactation and women with positive pregnancy test.
    Descrizione

    Pregnancy or lactation and women with positive pregnancy test.

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0032961
    SNOMED CT 2011_0131
    289908002
    MedDRA 14.1
    10036556
    LOINC Version 232
    MTHU035048
    UMLS CUI 2011AA
    C0006147
    MedDRA 14.1
    10006247
    UMLS CUI 2011AA
    C0043210
    SNOMED CT 2011_0131
    224526002
    UMLS CUI 2011AA
    C0240802
    SNOMED CT 2011_0131
    250423000
    MedDRA 14.1
    10036575
    Known hypersensitivity or allergic contact reactions to components of the study agents.
    Descrizione

    Known hypersensitivity or allergic contact reactions to components of the study agents.

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0020517
    SNOMED CT 2011_0131
    418634005
    ICD-10-CM Version 2010
    T78.40
    UMLS CUI 2011AA
    C0700624
    UMLS CUI 2011AA
    C0443191
    SNOMED CT 2011_0131
    263726009
    UMLS CUI 2011AA
    C1705248
    UMLS CUI 2011AA
    C0304229
    SNOMED CT 2011_0131
    902003
    Treatment with photosensitizing drugs.
    Descrizione

    Treatment with photosensitizing drugs.

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0039798
    UMLS CUI 2011AA
    C0162713
    SNOMED CT 2011_0131
    108817007
    Exposure to direct natural (sunlight) or artificial UV radiation on the back within 4 weeks prior to entering the study.
    Descrizione

    Exposure to direct natural (sunlight) or artificial UV radiation on the back within 4 weeks prior to entering the study.

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0332157
    SNOMED CT 2011_0131
    24932003
    UMLS CUI 2011AA
    C0038817
    SNOMED CT 2011_0131
    49926000
    UMLS CUI 2011AA
    C0205296
    SNOMED CT 2011_0131
    510009
    UMLS CUI 2011AA
    C2004457
    SNOMED CT 2011_0131
    71967004
    UMLS CUI 2011AA
    C0041625
    SNOMED CT 2011_0131
    41355003
    UMLS CUI 2011AA
    C0004600
    SNOMED CT 2011_0131
    123961009
    LOINC Version 232
    MTHU001427
    History of another photodermatosis, except polymorph light eruption (PLE).
    Descrizione

    History of another photodermatosis, except polymorph light eruption (PLE).

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0205394
    SNOMED CT 2011_0131
    74964007
    UMLS CUI 2011AA
    C0920193
    MedDRA 14.1
    10051246
    UMLS CUI 2011AA
    C1554961
    HL7 V3 2006_05
    E
    UMLS CUI 2011AA
    C0031736
    SNOMED CT 2011_0131
    238525001
    MedDRA 14.1
    10036087
    ICD-10-CM Version 2010
    L56.4
    Any current known skin malignancy or any history of skin malignancy within the previous 5 years or Xeroderma pigmentosum.
    Descrizione

    Any current known skin malignancy or any history of skin malignancy within the previous 5 years or Xeroderma pigmentosum.

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0007114
    SNOMED CT 2011_0131
    372130007
    MedDRA 14.1
    10040808
    ICD-10-CM Version 2010
    C44.9
    UMLS CUI 2011AA
    C0043346
    SNOMED CT 2011_0131
    44600005
    MedDRA 14.1
    10048220
    ICD-10-CM Version 2010
    Q82.1
    Initiation or change in the dose of any current systemic medication for the treatment of CLE within 8 weeks prior to standardized photoprovocation.
    Descrizione

    Initiation or change in the dose of any current systemic medication for the treatment of CLE within 8 weeks prior to standardized photoprovocation.

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C1704686
    UMLS CUI 2011AA
    C0178602
    SNOMED CT 2011_0131
    260911001
    UMLS CUI 2011AA
    C2347524
    UMLS CUI 2011AA
    C0205373
    SNOMED CT 2011_0131
    31099001
    UMLS CUI 2011AA
    C0013227
    UMLS CUI 2011AA
    C0039798
    UMLS CUI 2011AA
    C0024137
    SNOMED CT 2011_0131
    7119001
    MedDRA 14.1
    10056509
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C0430551
    SNOMED CT 2011_0131
    87724004
    Local therapy for the treatment of CLE within two weeks prior to standardized photoprovocation at the back of the patient
    Descrizione

    Local therapy for the treatment of CLE within two weeks prior to standardized photoprovocation at the back of the patient

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C1517925
    UMLS CUI 2011AA
    C0024137
    SNOMED CT 2011_0131
    7119001
    MedDRA 14.1
    10056509
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C0430551
    SNOMED CT 2011_0131
    87724004
    UMLS CUI 2011AA
    C0004600
    SNOMED CT 2011_0131
    123961009
    LOINC Version 232
    MTHU001427
    Acute exacerbation of CLE skin disease within 2 weeks prior to entering the study.
    Descrizione

    Acute exacerbation of CLE skin disease within 2 weeks prior to entering the study.

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0205178
    SNOMED CT 2011_0131
    272118002
    UMLS CUI 2011AA
    C1444749
    SNOMED CT 2011_0131
    410661009
    UMLS CUI 2011AA
    C0024137
    SNOMED CT 2011_0131
    7119001
    MedDRA 14.1
    10056509
    UMLS CUI 2011AA
    C0037274
    SNOMED CT 2011_0131
    95320005
    MedDRA 14.1
    10048768, 10040831
    LOINC Version 232
    MTHU031899
    Acute illness within 7 days prior to phototesting or major illness including infection or hospitalization within 1 month of study entry.
    Descrizione

    Acute illness within 7 days prior to phototesting or major illness including infection or hospitalization within 1 month of study entry.

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0205178
    SNOMED CT 2011_0131
    272118002
    UMLS CUI 2011AA
    C0221423
    SNOMED CT 2011_0131
    39104002
    MedDRA 14.1
    10040658
    ICD-10-CM Version 2010
    R69
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    CL426143
    UMLS CUI 2011AA
    C0205164
    SNOMED CT 2011_0131
    255603008
    UMLS CUI 2011AA
    C0221423
    SNOMED CT 2011_0131
    39104002
    MedDRA 14.1
    10040658
    ICD-10-CM Version 2010
    R69
    UMLS CUI 2011AA
    C0009450
    SNOMED CT 2011_0131
    257551009
    MedDRA 14.1
    10021789
    UMLS CUI 2011AA
    C0019993
    SNOMED CT 2011_0131
    394656005
    MedDRA 14.1
    10054112
    Anti-dsDNA (RIA) > 7 U/ml and/or at least one of the following criteria:
    Descrizione

    Anti-dsDNA (RIA) > 7 U/ml and/or at least one of the following criteria:

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C2747927
    MedDRA 14.1
    10069914
    UMLS CUI 2011AA
    C0034580
    SNOMED CT 2011_0131
    4613005
    HL7 V3 2006_05
    0104
    UMLS CUI 2011AA
    C0205447
    SNOMED CT 2011_0131
    38112003
    UMLS CUI 2011AA
    C0332282
    SNOMED CT 2011_0131
    255260001
    UMLS CUI 2011AA
    CL414621
    Serositis: pleuritis or pericarditis documented by electrocardiogram or rub or evidence of pericardial effusion
    Descrizione

    Serositis: pleuritis or pericarditis documented by electrocardiogram or rub or evidence of pericardial effusion

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0036749
    SNOMED CT 2011_0131
    370469003
    MedDRA 14.1
    10058556
    UMLS CUI 2011AA
    C0032231
    SNOMED CT 2011_0131
    196075003
    MedDRA 14.1
    10035618
    ICD-10-CM Version 2010
    R09.1
    ICD-9-CM Version 2011
    511
    UMLS CUI 2011AA
    C0031046
    SNOMED CT 2011_0131
    3238004
    MedDRA 14.1
    10034484
    CTCAE 1105E
    E10180
    UMLS CUI 2011AA
    C1301725
    SNOMED CT 2011_0131
    397934002
    UMLS CUI 2011AA
    C1623258
    SNOMED CT 2011_0131
    46825001
    MedDRA 14.1
    10014084
    UMLS CUI 2011AA
    C0232267
    SNOMED CT 2011_0131
    7036007
    MedDRA 14.1
    10049759
    UMLS CUI 2011AA
    C0031039
    SNOMED CT 2011_0131
    373945007
    MedDRA 14.1
    10034474
    CTCAE 1105E
    E10172
    Renal disorder: proteinuria > 0.5 g/d or > 3+, or cellular casts
    Descrizione

    Renal disorder: proteinuria > 0.5 g/d or > 3+, or cellular casts

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0022658
    SNOMED CT 2011_0131
    90708001
    MedDRA 14.1
    10029151
    ICD-10-CM Version 2010
    N18.9
    UMLS CUI 2011AA
    C0033687
    SNOMED CT 2011_0131
    29738008
    MedDRA 14.1
    10037032
    ICD-10-CM Version 2010
    R80
    ICD-9-CM Version 2011
    791.0
    CTCAE 1105E
    E13008
    UMLS CUI 2011AA
    C0427895
    SNOMED CT 2011_0131
    250445004
    Neurologic disorder: seizures or psychosis without other cause.
    Descrizione

    Neurologic disorder: seizures or psychosis without other cause.

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0027765
    SNOMED CT 2011_0131
    118940003
    MedDRA 14.1
    10029202
    ICD-10-CM Version 2010
    G98.8
    ICD-9-CM Version 2011
    349.9
    UMLS CUI 2011AA
    C0036572
    SNOMED CT 2011_0131
    91175000
    MedDRA 14.1
    10039910
    ICD-9-CM Version 2011
    780.39
    UMLS CUI 2011AA
    C0033975
    SNOMED CT 2011_0131
    69322001
    MedDRA 14.1
    10061920
    ICD-9-CM Version 2011
    290-299.99
    CTCAE 1105E
    E12954
    Patients with a documented HIV and/or hepatitis B or C infection.
    Descrizione

    Patients with a documented HIV and/or hepatitis B or C infection.

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C1301725
    SNOMED CT 2011_0131
    397934002
    UMLS CUI 2011AA
    C0019693
    SNOMED CT 2011_0131
    86406008
    MedDRA 14.1
    10020161
    LOINC Version 232
    MTHU020829
    ICD-10-CM Version 2010
    B20
    ICD-9-CM Version 2011
    042
    UMLS CUI 2011AA
    C0019163
    SNOMED CT 2011_0131
    66071002
    MedDRA 14.1
    10019731
    UMLS CUI 2011AA
    C0019196
    SNOMED CT 2011_0131
    50711007
    MedDRA 14.1
    10019744
    ICD-10-CM Version 2010
    B19.20
    ICD-9-CM Version 2011
    070.7
    Any medical condition, which would place the subject at undue risk of, or make it unlikely that follow-up-measurements could be obtained
    Descrizione

    Any medical condition, which would place the subject at undue risk of, or make it unlikely that follow-up-measurements could be obtained

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C1699700
    HL7 V3 2006_05
    MEDCCAT
    UMLS CUI 2011AA
    C1883420
    UMLS CUI 2011AA
    C0035647
    SNOMED CT 2011_0131
    30207005
    HL7 V3 2006_05
    RSK
    UMLS CUI 2011AA
    C0750558
    UMLS CUI 2011AA
    C1301820
    SNOMED CT 2011_0131
    398092000
    UMLS CUI 2011AA
    C1522577
    UMLS CUI 2011AA
    C0242485
    SNOMED CT 2011_0131
    122869004
    LOINC Version 232
    MTHU003137
    Ritorna all'inizio della pagina

    Similar models

    Eligibility

    1 moduli
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Einschlusskriterien
    CL425202 (UMLS CUI 2011AA)
    age 18 Years to 85 Years
    Item
    Alter 18 bis 85 Jahre
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    Patients with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE), or lupus erythematosus tumidus (LET) according to the Düsseldorf Classification 2004 (Kuhn and Ruzicka 2004) confirmed by histological analysis.
    Item
    Patients with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE), or lupus erythematosus tumidus (LET) according to the Düsseldorf Classification 2004 (Kuhn and Ruzicka 2004) confirmed by histological analysis.
    boolean
    C0024140 (UMLS CUI 2011AA)
    239891002 (SNOMED CT 2011_0131)
    10057903 (MedDRA 14.1)
    L93.1 (ICD-10-CM Version 2010)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C0024138 (UMLS CUI 2011AA)
    200938002 (SNOMED CT 2011_0131)
    10013072 (MedDRA 14.1)
    L93.0 (ICD-10-CM Version 2010)
    C0406636 (UMLS CUI 2011AA)
    200941006 (SNOMED CT 2011_0131)
    C0205462 (UMLS CUI 2011AA)
    67151002 (SNOMED CT 2011_0131)
    C0750484 (UMLS CUI 2011AA)
    Women of childbearing potential with a negative pregnancy test at screening (urine test) and using a medically accepted contraceptive regimen (intra-uterine device, partner's vasectomy, >3 months previous hormonal contraception (oestrogen plus gestagen pill, depot injections, or subcutaneous depot) combined with a barrier method (preservative, vaginal diaphragm, cervical cap, spermicide) during the study and for 8 weeks after the last UV exposure.
    Item
    Women of childbearing potential with a negative pregnancy test at screening (urine test) and using a medically accepted contraceptive regimen (intra-uterine device, partner's vasectomy, >3 months previous hormonal contraception (oestrogen plus gestagen pill, depot injections, or subcutaneous depot) combined with a barrier method (preservative, vaginal diaphragm, cervical cap, spermicide) during the study and for 8 weeks after the last UV exposure.
    boolean
    C0043210 (UMLS CUI 2011AA)
    224526002 (SNOMED CT 2011_0131)
    C1148523 (UMLS CUI 2011AA)
    C0237399 (UMLS CUI 2011AA)
    C0430057 (UMLS CUI 2011AA)
    167254001 (SNOMED CT 2011_0131)
    10036577 (MedDRA 14.1)
    C0700589 (UMLS CUI 2011AA)
    146680009 (SNOMED CT 2011_0131)
    10010808 (MedDRA 14.1)
    C0021900 (UMLS CUI 2011AA)
    268460000 (SNOMED CT 2011_0131)
    10022745 (MedDRA 14.1)
    C0420842 (UMLS CUI 2011AA)
    268457007 (SNOMED CT 2011_0131)
    CL424941 (UMLS CUI 2011AA)
    C0014939 (UMLS CUI 2011AA)
    41598000, 61946003 (SNOMED CT 2011_0131)
    MTHU003480 (LOINC Version 232)
    C0033306 (UMLS CUI 2011AA)
    116614001, 20249007 (SNOMED CT 2011_0131)
    C0419530 (UMLS CUI 2011AA)
    268464009 (SNOMED CT 2011_0131)
    C0205195 (UMLS CUI 2011AA)
    89780004 (SNOMED CT 2011_0131)
    C0004764 (UMLS CUI 2011AA)
    225370004 (SNOMED CT 2011_0131)
    C0677582 (UMLS CUI 2011AA)
    C0042241 (UMLS CUI 2011AA)
    20359006 (SNOMED CT 2011_0131)
    C0493327 (UMLS CUI 2011AA)
    368441006 (SNOMED CT 2011_0131)
    10007183 (MedDRA 14.1)
    C0037862 (UMLS CUI 2011AA)
    425484006 (SNOMED CT 2011_0131)
    Women clinically sterile (post-menopausal, undergone hysterectomy or tubal ligation).
    Item
    Women clinically sterile (post-menopausal, undergone hysterectomy or tubal ligation).
    boolean
    C0043210 (UMLS CUI 2011AA)
    224526002 (SNOMED CT 2011_0131)
    C0205210 (UMLS CUI 2011AA)
    58147004 (SNOMED CT 2011_0131)
    C0021359 (UMLS CUI 2011AA)
    8619003 (SNOMED CT 2011_0131)
    10021926 (MedDRA 14.1)
    C0232970 (UMLS CUI 2011AA)
    76498008 (SNOMED CT 2011_0131)
    C0020699 (UMLS CUI 2011AA)
    236886002 (SNOMED CT 2011_0131)
    10021151 (MedDRA 14.1)
    C0520483 (UMLS CUI 2011AA)
    77543007 (SNOMED CT 2011_0131)
    10044722 (MedDRA 14.1)
    Actively cooperating to participate in the study, to follow the instructions of the investigator and to attend the centre at the agreed times.
    Item
    Actively cooperating to participate in the study, to follow the instructions of the investigator and to attend the centre at the agreed times.
    boolean
    C0392337 (UMLS CUI 2011AA)
    C0679823 (UMLS CUI 2011AA)
    PART (HL7 V3 2006_05)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C0525058 (UMLS CUI 2011AA)
    Development of skin lesions any time under current systemic treatment if patient is receiving systemic medication for the treatment of CLE.
    Item
    Development of skin lesions any time under current systemic treatment if patient is receiving systemic medication for the treatment of CLE.
    boolean
    C1511795 (UMLS CUI 2011AA)
    C0037284 (UMLS CUI 2011AA)
    95324001 (SNOMED CT 2011_0131)
    10040882 (MedDRA 14.1)
    C0521116 (UMLS CUI 2011AA)
    15240007 (SNOMED CT 2011_0131)
    C1515119 (UMLS CUI 2011AA)
    C0024137 (UMLS CUI 2011AA)
    7119001 (SNOMED CT 2011_0131)
    10056509 (MedDRA 14.1)
    Signed informed consent form after the nature of the study has been fully explained.
    Item
    Signed informed consent form after the nature of the study has been fully explained.
    boolean
    C0021430 (UMLS CUI 2011AA)
    Item Group
    Ausschlusskriterien
    CL425201 (UMLS CUI 2011AA)
    Pregnancy or lactation and women with positive pregnancy test.
    Item
    Pregnancy or lactation and women with positive pregnancy test.
    boolean
    C0032961 (UMLS CUI 2011AA)
    289908002 (SNOMED CT 2011_0131)
    10036556 (MedDRA 14.1)
    MTHU035048 (LOINC Version 232)
    C0006147 (UMLS CUI 2011AA)
    10006247 (MedDRA 14.1)
    C0043210 (UMLS CUI 2011AA)
    224526002 (SNOMED CT 2011_0131)
    C0240802 (UMLS CUI 2011AA)
    250423000 (SNOMED CT 2011_0131)
    10036575 (MedDRA 14.1)
    Known hypersensitivity or allergic contact reactions to components of the study agents.
    Item
    Known hypersensitivity or allergic contact reactions to components of the study agents.
    boolean
    C0020517 (UMLS CUI 2011AA)
    418634005 (SNOMED CT 2011_0131)
    T78.40 (ICD-10-CM Version 2010)
    C0700624 (UMLS CUI 2011AA)
    C0443191 (UMLS CUI 2011AA)
    263726009 (SNOMED CT 2011_0131)
    C1705248 (UMLS CUI 2011AA)
    C0304229 (UMLS CUI 2011AA)
    902003 (SNOMED CT 2011_0131)
    Treatment with photosensitizing drugs.
    Item
    Treatment with photosensitizing drugs.
    boolean
    C0039798 (UMLS CUI 2011AA)
    C0162713 (UMLS CUI 2011AA)
    108817007 (SNOMED CT 2011_0131)
    Exposure to direct natural (sunlight) or artificial UV radiation on the back within 4 weeks prior to entering the study.
    Item
    Exposure to direct natural (sunlight) or artificial UV radiation on the back within 4 weeks prior to entering the study.
    boolean
    C0332157 (UMLS CUI 2011AA)
    24932003 (SNOMED CT 2011_0131)
    C0038817 (UMLS CUI 2011AA)
    49926000 (SNOMED CT 2011_0131)
    C0205296 (UMLS CUI 2011AA)
    510009 (SNOMED CT 2011_0131)
    C2004457 (UMLS CUI 2011AA)
    71967004 (SNOMED CT 2011_0131)
    C0041625 (UMLS CUI 2011AA)
    41355003 (SNOMED CT 2011_0131)
    C0004600 (UMLS CUI 2011AA)
    123961009 (SNOMED CT 2011_0131)
    MTHU001427 (LOINC Version 232)
    History of another photodermatosis, except polymorph light eruption (PLE).
    Item
    History of another photodermatosis, except polymorph light eruption (PLE).
    boolean
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0205394 (UMLS CUI 2011AA)
    74964007 (SNOMED CT 2011_0131)
    C0920193 (UMLS CUI 2011AA)
    10051246 (MedDRA 14.1)
    C1554961 (UMLS CUI 2011AA)
    E (HL7 V3 2006_05)
    C0031736 (UMLS CUI 2011AA)
    238525001 (SNOMED CT 2011_0131)
    10036087 (MedDRA 14.1)
    L56.4 (ICD-10-CM Version 2010)
    Any current known skin malignancy or any history of skin malignancy within the previous 5 years or Xeroderma pigmentosum.
    Item
    Any current known skin malignancy or any history of skin malignancy within the previous 5 years or Xeroderma pigmentosum.
    boolean
    C0007114 (UMLS CUI 2011AA)
    372130007 (SNOMED CT 2011_0131)
    10040808 (MedDRA 14.1)
    C44.9 (ICD-10-CM Version 2010)
    C0043346 (UMLS CUI 2011AA)
    44600005 (SNOMED CT 2011_0131)
    10048220 (MedDRA 14.1)
    Q82.1 (ICD-10-CM Version 2010)
    Initiation or change in the dose of any current systemic medication for the treatment of CLE within 8 weeks prior to standardized photoprovocation.
    Item
    Initiation or change in the dose of any current systemic medication for the treatment of CLE within 8 weeks prior to standardized photoprovocation.
    boolean
    C1704686 (UMLS CUI 2011AA)
    C0178602 (UMLS CUI 2011AA)
    260911001 (SNOMED CT 2011_0131)
    C2347524 (UMLS CUI 2011AA)
    C0205373 (UMLS CUI 2011AA)
    31099001 (SNOMED CT 2011_0131)
    C0013227 (UMLS CUI 2011AA)
    C0039798 (UMLS CUI 2011AA)
    C0024137 (UMLS CUI 2011AA)
    7119001 (SNOMED CT 2011_0131)
    10056509 (MedDRA 14.1)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C0430551 (UMLS CUI 2011AA)
    87724004 (SNOMED CT 2011_0131)
    Local therapy for the treatment of CLE within two weeks prior to standardized photoprovocation at the back of the patient
    Item
    Local therapy for the treatment of CLE within two weeks prior to standardized photoprovocation at the back of the patient
    boolean
    C1517925 (UMLS CUI 2011AA)
    C0024137 (UMLS CUI 2011AA)
    7119001 (SNOMED CT 2011_0131)
    10056509 (MedDRA 14.1)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C0430551 (UMLS CUI 2011AA)
    87724004 (SNOMED CT 2011_0131)
    C0004600 (UMLS CUI 2011AA)
    123961009 (SNOMED CT 2011_0131)
    MTHU001427 (LOINC Version 232)
    Acute exacerbation of CLE skin disease within 2 weeks prior to entering the study.
    Item
    Acute exacerbation of CLE skin disease within 2 weeks prior to entering the study.
    boolean
    C0205178 (UMLS CUI 2011AA)
    272118002 (SNOMED CT 2011_0131)
    C1444749 (UMLS CUI 2011AA)
    410661009 (SNOMED CT 2011_0131)
    C0024137 (UMLS CUI 2011AA)
    7119001 (SNOMED CT 2011_0131)
    10056509 (MedDRA 14.1)
    C0037274 (UMLS CUI 2011AA)
    95320005 (SNOMED CT 2011_0131)
    10048768, 10040831 (MedDRA 14.1)
    MTHU031899 (LOINC Version 232)
    Acute illness within 7 days prior to phototesting or major illness including infection or hospitalization within 1 month of study entry.
    Item
    Acute illness within 7 days prior to phototesting or major illness including infection or hospitalization within 1 month of study entry.
    boolean
    C0205178 (UMLS CUI 2011AA)
    272118002 (SNOMED CT 2011_0131)
    C0221423 (UMLS CUI 2011AA)
    39104002 (SNOMED CT 2011_0131)
    10040658 (MedDRA 14.1)
    R69 (ICD-10-CM Version 2010)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    CL426143 (UMLS CUI 2011AA)
    C0205164 (UMLS CUI 2011AA)
    255603008 (SNOMED CT 2011_0131)
    C0221423 (UMLS CUI 2011AA)
    39104002 (SNOMED CT 2011_0131)
    10040658 (MedDRA 14.1)
    R69 (ICD-10-CM Version 2010)
    C0009450 (UMLS CUI 2011AA)
    257551009 (SNOMED CT 2011_0131)
    10021789 (MedDRA 14.1)
    C0019993 (UMLS CUI 2011AA)
    394656005 (SNOMED CT 2011_0131)
    10054112 (MedDRA 14.1)
    Anti-dsDNA (RIA) > 7 U/ml and/or at least one of the following criteria:
    Item
    Anti-dsDNA (RIA) > 7 U/ml and/or at least one of the following criteria:
    boolean
    C2747927 (UMLS CUI 2011AA)
    10069914 (MedDRA 14.1)
    C0034580 (UMLS CUI 2011AA)
    4613005 (SNOMED CT 2011_0131)
    0104 (HL7 V3 2006_05)
    C0205447 (UMLS CUI 2011AA)
    38112003 (SNOMED CT 2011_0131)
    C0332282 (UMLS CUI 2011AA)
    255260001 (SNOMED CT 2011_0131)
    CL414621 (UMLS CUI 2011AA)
    Serositis: pleuritis or pericarditis documented by electrocardiogram or rub or evidence of pericardial effusion
    Item
    Serositis: pleuritis or pericarditis documented by electrocardiogram or rub or evidence of pericardial effusion
    boolean
    C0036749 (UMLS CUI 2011AA)
    370469003 (SNOMED CT 2011_0131)
    10058556 (MedDRA 14.1)
    C0032231 (UMLS CUI 2011AA)
    196075003 (SNOMED CT 2011_0131)
    10035618 (MedDRA 14.1)
    R09.1 (ICD-10-CM Version 2010)
    511 (ICD-9-CM Version 2011)
    C0031046 (UMLS CUI 2011AA)
    3238004 (SNOMED CT 2011_0131)
    10034484 (MedDRA 14.1)
    E10180 (CTCAE 1105E)
    C1301725 (UMLS CUI 2011AA)
    397934002 (SNOMED CT 2011_0131)
    C1623258 (UMLS CUI 2011AA)
    46825001 (SNOMED CT 2011_0131)
    10014084 (MedDRA 14.1)
    C0232267 (UMLS CUI 2011AA)
    7036007 (SNOMED CT 2011_0131)
    10049759 (MedDRA 14.1)
    C0031039 (UMLS CUI 2011AA)
    373945007 (SNOMED CT 2011_0131)
    10034474 (MedDRA 14.1)
    E10172 (CTCAE 1105E)
    Renal disorder: proteinuria > 0.5 g/d or > 3+, or cellular casts
    Item
    Renal disorder: proteinuria > 0.5 g/d or > 3+, or cellular casts
    boolean
    C0022658 (UMLS CUI 2011AA)
    90708001 (SNOMED CT 2011_0131)
    10029151 (MedDRA 14.1)
    N18.9 (ICD-10-CM Version 2010)
    C0033687 (UMLS CUI 2011AA)
    29738008 (SNOMED CT 2011_0131)
    10037032 (MedDRA 14.1)
    R80 (ICD-10-CM Version 2010)
    791.0 (ICD-9-CM Version 2011)
    E13008 (CTCAE 1105E)
    C0427895 (UMLS CUI 2011AA)
    250445004 (SNOMED CT 2011_0131)
    Neurologic disorder: seizures or psychosis without other cause.
    Item
    Neurologic disorder: seizures or psychosis without other cause.
    boolean
    C0027765 (UMLS CUI 2011AA)
    118940003 (SNOMED CT 2011_0131)
    10029202 (MedDRA 14.1)
    G98.8 (ICD-10-CM Version 2010)
    349.9 (ICD-9-CM Version 2011)
    C0036572 (UMLS CUI 2011AA)
    91175000 (SNOMED CT 2011_0131)
    10039910 (MedDRA 14.1)
    780.39 (ICD-9-CM Version 2011)
    C0033975 (UMLS CUI 2011AA)
    69322001 (SNOMED CT 2011_0131)
    10061920 (MedDRA 14.1)
    290-299.99 (ICD-9-CM Version 2011)
    E12954 (CTCAE 1105E)
    Patients with a documented HIV and/or hepatitis B or C infection.
    Item
    Patients with a documented HIV and/or hepatitis B or C infection.
    boolean
    C1301725 (UMLS CUI 2011AA)
    397934002 (SNOMED CT 2011_0131)
    C0019693 (UMLS CUI 2011AA)
    86406008 (SNOMED CT 2011_0131)
    10020161 (MedDRA 14.1)
    MTHU020829 (LOINC Version 232)
    B20 (ICD-10-CM Version 2010)
    042 (ICD-9-CM Version 2011)
    C0019163 (UMLS CUI 2011AA)
    66071002 (SNOMED CT 2011_0131)
    10019731 (MedDRA 14.1)
    C0019196 (UMLS CUI 2011AA)
    50711007 (SNOMED CT 2011_0131)
    10019744 (MedDRA 14.1)
    B19.20 (ICD-10-CM Version 2010)
    070.7 (ICD-9-CM Version 2011)
    Any medical condition, which would place the subject at undue risk of, or make it unlikely that follow-up-measurements could be obtained
    Item
    Any medical condition, which would place the subject at undue risk of, or make it unlikely that follow-up-measurements could be obtained
    boolean
    C1699700 (UMLS CUI 2011AA)
    MEDCCAT (HL7 V3 2006_05)
    C1883420 (UMLS CUI 2011AA)
    C0035647 (UMLS CUI 2011AA)
    30207005 (SNOMED CT 2011_0131)
    RSK (HL7 V3 2006_05)
    C0750558 (UMLS CUI 2011AA)
    C1301820 (UMLS CUI 2011AA)
    398092000 (SNOMED CT 2011_0131)
    C1522577 (UMLS CUI 2011AA)
    C0242485 (UMLS CUI 2011AA)
    122869004 (SNOMED CT 2011_0131)
    MTHU003137 (LOINC Version 232)
    Ritorna all'inizio della pagina 

    Aiuto

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial